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EZETIMIBE is a brand name for Ezetimibe. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Primary Hypercholesterolaemia Ezetimibe co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone. Ezetimibe monotherapy…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. The recommended dose is one Ezetimibe 10 mg tablet daily. Ezetimibe can be administered at any time of the day, with or without food.
When ezetimibe is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.
Use in Patients with Coronary Heart Disease and ACS Event History For incremental cardiovascular event reduction in patients with coronary heart disease and ACS event history, Ezetimibe 10 mg may be administered with a statin with proven cardiovascular benefit.
Co-administration with bile acid sequestrants Dosing of ezetimibe should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. 2). Paediatric Population Initiation of treatment must be performed under review of a specialist.
Children and adolescents ≥ 6 years The safety and efficacy of ezetimibe in children aged 6 to 17 years has not been established. 2 but no recommendation on a posology can be made. When ezetimibe is administered with a statin, the dosage instructions for the statin in children should be consulted.
Children <6 years The safety and efficacy of Ezetimibe in children aged < 6 years has not Page 3 of 25 been established. No data are available. Hepatic Impairment No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6).
Treatment with ezetimibe is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction. ). 2). Method of administration Oral
Tabulated list of adverse reactions (clinical studies and post-marketing experience) In clinical studies of up to 112 weeks duration, ezetimibe 10 mg daily was administered alone in 2,396 patients, with a statin in 11308 patients or with fenofibrate in 185 patients.
Adverse reactions were usually mild and transient. The overall incidence of side effects was similar between ezetimibe and placebo. Similarly, the discontinuation rate due to adverse experiences was comparable between ezetimibe and placebo.
Ezetimibe administered alone or co-administered with a statin The following adverse reactions were observed in patients treated with ezetimibe (n=2396) and at a greater incidence than placebo (n=1159) or in patients treated with ezetimibe co-administered with a statin (n=11308) Page 9 of 25 and at a greater incidence than statin administered alone (n=9361).
Post- marketing adverse reactions were derived from reports containing ezetimibe either administered alone or with a statin. Adverse reactions observed in clinical studies of ezetimibe (as a monotherapy or co-administered with a statin) or ezetimibe reported from post-marketing use either administered alone or with a statin are listed in Table 1.
These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) very rare (<1/10,000) and not known (cannot be estimated from the available data).
4). General disorders and administration site conditions Common fatigue Uncommon chest pain; pain; asthenia; oedema peripheral Investigations Common ALT and/or AST increased Uncommon blood CPK increased; gammaglutamyltransferase increased; liver function test abnormal Page 11 of 25 Ezetimibe co-administered with fenofibrate Gastrointestinal disorders: abdominal pain (common).
When ezetimibe is co-administered with a statin, please refer to the SmPC for that particular medicinal product. Liver enzymes In controlled co-administration trials in patients receiving ezetimibe with a statin, consecutive transaminase elevations (≥3 X the upper limit of normal [ULN]) have been observed.
8).
In the IMProved Reduction of Outcomes:
Vytorin Efficacy International Trial (IMPROVE-IT), 18,144 patients with coronary heart disease and Page 4 of 25 ACS event history were randomised to receive ezetimibe/simvastatin 10/40 mg daily (n=9067) or simvastatin 40 mg daily (n=9077).
3% for simvastatin. 8). 8). Skeletal muscle In post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin concomitantly with ezetimibe.
However, rhabdomyolysis has been reported very rarely with ezetimibe monotherapy and very rarely with the addition of ezetimibe to other agents known to be associated with increased risk of rhabdomyolysis. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase (CPK) level >10 times the ULN, ezetimibe, any statin, and any of these other agents that the patient is taking concomitantly should be immediately discontinued.
8). In IMPROVE-IT, 18,144 patients with coronary heart disease and ACS event history were randomised to receive ezetimibe/simvastatin 10/40 mg daily (n=9067) or simvastatin 40 mg daily (n=9077). 1% for simvastatin, where myopathy was defined as unexplained muscle weakness or pain with a serum CK ≥10 times ULN or two consecutive observations of CK ≥5 and <10 times ULN.
2% for simvastatin, where rhabdomyolysis was defined as unexplained muscle weakness or pain with a serum CK ≥10 times ULN with evidence of renal injury, ≥5 times ULN and <10 times ULN on two consecutive occasions with evidence of renal injury or CK ≥10,000 IU/L without evidence of renal injury.
1. When ezetimibe is co-administered with a statin, please refer to the SmPC for that particular medicinal product. Therapy with ezetimibe co-administered with a statin is contraindicated during pregnancy and lactation. Ezetimibe co-administered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In a multicentre, double-blind, placebo-controlled, clinical study in patients with mixed hyperlipidaemia, 625 patients were treated for up to 12 weeks and 576 patients for up to 1 year. In this study, 172 patients treated with ezetimibe and fenofibrate completed 12 weeks of therapy, and 230 patients treated with ezetimibe and fenofibrate (including 109 who received ezetimibe alone for the first 12 weeks) completed 1 year of therapy.
This study was not designed to compare treatment groups for infrequent events. 4) for fenofibrate monotherapy and ezetimibe co-administered with fenofibrate, respectively, adjusted for treatment exposure. 5). 1% (1 patient) of the ezetimibe patients compared to 0% in the placebo group.
There were no elevations of CPK (≥ 10X ULN). No cases of myopathy were reported. In a separate study involving adolescent (10 to 17 years of age) patients with heterozygous familial hypercholesterolaemia (n = 248), elevations of ALT and/or AST (≥3X ULN, consecutive) were observed in 3% (4 patients) of the ezetimibe/simvastatin patients compared to 2% (2 patients) in the simvastatin monotherapy group; these figures were respectively 2% (2 patients) and 0% for elevation of CPK (≥ 10X ULN).
No cases of myopathy were reported. These trials were not suited for comparison of rare adverse drug reactions. 0 years. 1% for patients treated with simvastatin. 1% for simvastatin, where myopathy was defined as unexplained muscle weakness or pain with a serum CK ≥10 times ULN or two consecutive observations of CK ≥5 and <10 times ULN.
2% for simvastatin, where rhabdomyolysis was defined as unexplained muscle weakness or pain with a serum CK ≥10 times ULN […]
). 8). 2). Paediatric population Efficacy and safety of ezetimibe in patients 6 to 10 years of age with heterozygous familial or non-familial hypercholesterolemia have been evaluated in a 12-week placebo-controlled clinical trial. 2). Ezetimibe has not been studied in patients younger than 6 years of age.
). Efficacy and safety of ezetimibe co-administered with simvastatin in patients 10 to 17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial in adolescent boys (Tanner stage II or above) and in girls who were at least one year post-menarche.
In this limited controlled study, there was generally no detectable effect on growth or sexual maturation in the adolescent boys or girls, or any effect on menstrual cycle length in girls. 8). The safety and efficacy of ezetimibe co-administered with doses of simvastatin above 40 mg daily have not been studied in paediatric patients 10 to 17 years of age.
8). The long-term efficacy of therapy with ezetimibe in patients below 17 years of age to reduce morbidity and mortality in adulthood has not been studied. Fibrates The safety and efficacy of ezetimibe administered with fibrates have not been established.
8). Ciclosporin Caution should be exercised when initiating ezetimibe in the setting of ciclosporin. 5). 5). Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase […]